ELA026, a novel monoclonal antibody targeting SIRP-α/β1/γ on myeloid cells and T lymphocytes, aims to curb hyperinflammation in Secondary Hemophagocytic Lymphohistiocytosis (sHLH). The Phase Ib trial, an ongoing open-label, multi-dose, single-arm study across multiple centers, evaluates ELA026's safety, efficacy, biomarker correlations, and identifies dosing for Phase II/III trials. At EHA 2024, the oral presentation titled "ELA026 Targets SIRP (+) Immune Cells, Yielding High Response Rates and Enhanced 2-Month Survival in Treatment-Naïve mHLH in Phase I Study," highlighted promising outcomes.

Analysis of sHLH patients across three cohorts in an ongoing Phase Ib clinical study revealed significant findings. Most patients had malignancy-associated HLH (mHLH), known for its poor prognosis with a 50% mortality rate at two months. ELA026 demonstrated a favorable safety profile with manageable adverse events. In Cohorts 1 and 2 (n=12), ELA026 achieved a 75% overall response rate (ORR) by Week 4. Cohort 3 enrollment is ongoing (n=5, as of 17th April 2024). Among eight treatment-naïve mHLH patients, ELA026 achieved a 100% ORR by week 4 with 88% survival at two months. The study also identified correlations between pharmacodynamic and biomarker responses with clinical outcomes. The Phase 1b trial has expanded to include up to 20 patients in Cohort 3, aiming to further evaluate ELA026 in frontline treatment for various sHLH subtypes.

KOL insights

“These data show very promising results for ELA026 as a potential treatment for sHLH, which is a challenging disease that is devastating for patients and has no approved treatment options. Notably, the analysis reveals improved survival was achieved with ELA026 in treatment-naïve mHLH patients, suggesting benefit from early treatment intervention for patients with this rapidly progressing disease. ” – MD, United States

Conclusion

Late-breaking presentation at EHA brings promising early data showing promising outcomes, including high response rates and enhanced two-month survival in treatment-naïve mHLH patients, indicating ELA026's potential as a primary therapy. This survival benefit is crucial, demonstrating effectiveness of ELA026 in managing hyperinflammation in sHLH and enabling patients with mHLH to pursue curative cancer treatments. ELA026 exhibited a notable ORR across various sHLH patients and demonstrated a favorable safety profile in this severe hyperinflammatory condition. Ongoing enrollment aims to further assess ELA026's safety and efficacy, addressing the urgent needs of sHLH patients lacking approved therapies.